Apparatus, system and operation method for the treatment of male sexual dysfunction

ABSTRACT

An apparatus and a system for treating a sexual dysfunctional male patient comprise an implanted at least one vibrator adapted to stimulate at least a part of the sexually responsive tissue of the penis of the patient by vibration of said vibrator and contact between said vibrator and at least one area of the sexually responsive tissue. There is also provided a surgical method comprising the apparatus and the system.

TECHNICAL FIELD

The present invention relates to an apparatus, a system, and a methodfor the treatment of male sexual dysfunction.

BACKGROUND

There is a lack of therapies for treating male sexual dysfunction (MSD).Male sexual dysfunction such as disorders of sexual desire, arousal ororgasm is a common problem. Both biological and psychological factorscontribute to MSD. Male sexual dysfunction in the form of maledysfunctional ejaculation (MDE) is one area where there is a lack oftherapy.

Available treatments include psychological counselling to pairs orindividuals. Where side effects of medication contribute to MSD,altering medication or dosage may help. However, there is a need forimproved treatment of MSD.

During sexual arousal of the male, vasocongestion of the pelvic regionleads to engorgement of the genitalia with blood leading to swelling ofthe external genitalia and erection of the penis. In the male, thecorpus cavernosa are two paired symmetrical extensions in the penis andengorgement of these is an important step during sexual arousal of themale.

Male sexual arousal is enhanced by stimulation of the penis, by touchingor caressing the penis, which for example contributes to arousal.

Hand held or other external devices that stimulate the penis arewell-known. One example is a sexual aid that vibrates. There has beenproposed a device for treating MSD that applies a vacuum or suction tothe penis. This will create a negative pressure that promotes theengorgement of the penis with blood.

Medical implants that contribute to erection by having a expandableelongated prosthesis that assists in erection are previously known.

Medication against MSD includes sildenafil (Viagra), which has a numberof side effects and seems to be most effective when there is still someremaining erectile function.

The local administration of prostaglandins to the male genitalia inorder to treat MSD is also known.

The proposed device, also called vibrator, is implanted and may beimplanted at an appropriate location in the male genitals, or in apenile implant for curing erectile impotence. An advantage with theimplantation of a vibrator is that it is always at hand and canconveniently be switched on before or during sexual intercourse. Handheld devices are more likely to cause embarrassment.

SUMMARY

It is an object of the present invention to obviate at least some of thedisadvantages in the prior art and provide a new dimension to treat malesexual dysfunction, e.g. MSD, positively affecting sexual stimuli andorgasm.

One advantage is that the likelihood to get orgasm will increase by thevibrator.

Another advantage is that the sexual response to sexual stimuli willincrease.

In a first aspect there is provided an apparatus for treating a sexualdysfunctional male patient, comprising an implantable at least onevibrator adapted to be implanted within at least one of the two corpuscavernosa of a human patient, said vibrator adapted to cause vibrationin at least one of the corpus cavernosum for stimulating the sexuallyresponsive tissue of the penis.

The apparatus may comprise at least one operation device adapted tooperate said at least one vibrator. The operation device may be anintegrated part of the vibrator or the vibrator and operation device maybe the same and one unit. The at least one operation device may be alsoimplanted at a distance from the at least one vibrator.

In one embodiment the vibrator is adapted to be implanted in at leastone elongated corpus cavernosum implant, where the elongated expandableimplant is hydraulically operated.

The apparatus including at least one vibrator can be adapted to beimplanted in at least one of two elongated corpus cavernosum implants,two hydraulic elongated expandable implants comprising a reservoir eachfilled with hydraulic fluid, when implanted.

Further embodiments comprise at least one vibrating device is adapted tobe implanted in the region of the sexually responsive tissue of thepenis, wherein the at least one vibrating device is adapted to createvibration preferable with a frequency from 0.1 to 10 000 Hz, and whereinthe at least one vibrating device is adapted to create vibrationpreferable with an amplitude of from 0.01 to 30 mm.

The apparatus may further comprise a control device for manuallycontrolling the at least one vibrating device from outside the patient'sbody, and may further comprise a control device for controlling theintensity of the vibration.

Alternatively the apparatus may comprise a control device and at leastone sensor adapted to detect a physiological parameter of the patientand/or a functional parameter of the apparatus, wherein said controldevice comprises a control unit adapted to automatically control the atleast one vibrating device based on input from said at least one sensor.

The operation device may comprise many different embodiments such as:

an electromagnetic or magnetic device, wherein the vibration is achievedby said electromagnetic or magnetic device; an electric motor, whereinthe vibration is achieved by said electric motor; a hydraulic device,wherein the vibration is achieved by said hydraulic device; a mechanicaldevice, wherein the vibration is achieved by said mechanical device; amotor, wherein the vibration is achieved by said motor; a piezoelectricdevice, wherein the vibration is achieved by said piezoelectric device.

In a second aspect there is provided a system for energizing andcontrolling the apparatus.

In a preferred embodiment, the system comprises at least one switchimplantable in the patient for manually and non-invasively controllingthe apparatus

In another preferred embodiment, the system comprises a wireless remotecontrol for non-invasively controlling the apparatus.

In a preferred embodiment, the system comprises a hydraulic operationdevice for operating the apparatus.

In one embodiment, the system comprises a motor or a pump for operatingthe apparatus.

In a third aspect there is provided a method for operating and usingsaid vibrator. In a first aspect there is provided an operation methodusing the apparatus comprising the steps of: creating an opening in theskin or penile wall of the male patient, dissecting an area of thesexually responsive tissue, placing the vibrator within said area,adapted to postoperatively stimulate said sexually responsive tissue onpatient command.

Further steps may include placing an operation device and a power sourcewithin the body.

The step of placing a vibrator may comprise placing an integrated unitcomprising the vibrator and an operation device in the same integratedunit.

The step of placing a power source may comprise; placing a control unitand a rechargeable battery remote from said sexually responsive tissue.

The operation method preferable includes controlling said vibratorpost-operatively and non-invasively from outside the body.

The operation method may include a laparoscopic operation method,wherein the step of creating an opening in the skin or penile wall ofthe male patient comprises: inserting a tube or needle into thepatient's body, filling the tube or needle with a gas and therebyexpanding a cavity within the male patients body, inserting at least twolaparoscopic trocars into said cavity, inserting at least one cameratrough at least one laparoscopic trocar and inserting at least onedissecting tool through at least one laparoscopic trocar.

Further aspects and embodiments are defined in the appended claims,which are specifically incorporated herein by reference.

In a first aspect there is provided an apparatus for treating a sexualdysfunctional male patient, comprising an implantable at least onevibrator adapted to be implanted within at least one of the two corpuscavernosa of a human patient, said vibrator adapted to cause vibrationin at least one of the corpus cavernosum for stimulating the sexuallyresponsive tissue of the penis.

In a main embodiment there is provided an apparatus comprising at leastone operation device adapted to operate said at least one vibrator,where the at least one vibrating device is adapted to be implanted inthe region of the sexually responsive tissue of the penis. The vibratingdevice is adapted to move with a frequency from 0.1 to 10 000 Hz andwith an amplitude of from 0.01 to 30 mm. In one embodiment the at leastone vibrating device is adapted to create vibrations along more than oneaxis.

In one embodiment the invention further comprises a control device formanually controlling the at least one vibrating device from outside thepatient's body. The control device controls the intensity of vibration.The control device may independently control amplitude and frequency ofthe vibration in the two different axes.

In another embodiment the apparatus comprises a control device and atleast one sensor adapted to detect a physiological parameter of thepatient and/or a functional parameter of the apparatus, wherein saidcontrol device comprises a control unit adapted to automatically controlthe at least one vibrating device based on input from said at least onesensor.

In another embodiment the at least one vibrating device is controlled byan endogenous signal.

In one embodiment the at least one operation device is adapted to beimplanted at a distance from the at least one vibrating device.

In one embodiment there are at least two vibrating devices, adapted tobe placed in the region of the sexually responsive tissue of the penis.

In one embodiment the operation device is an integrated part of thevibrator or the vibrator and operation device are the same and one unit.

The vibration may be achieved by different means in differentembodiments. Thus, operation device may comprise an electric motor, ahydraulic device, a mechanical device, or a magnetic device.

In one embodiment the apparatus comprises at least one implantablereservoir, adapted to be implanted in the sexually responsive tissue ofthe penis of the patient, wherein said at least one vibrator is placedin said at least one reservoir.

In one embodiment the apparatus comprises at least one expandableprosthesis adapted for implantation in the penis and adapted to beadjusted to temporarily achieve enlarged status of the penis. Theprosthesis may be implanted in the corpus cavernosum and can be made ofa flexible material, such as silicone, and can be controlled andenergized in the same manner as the vibrator. For example, theprosthesis can be regulated by a hydraulic mechanism and may comprise apump.

In one embodiment the apparatus is adapted to be adjusted to temporarilyachieve enlarged status of the penis. In one embodiment the prosthesisis made of silicone.

The apparatus may be operated by a piezoelectric element, en electricmotor, an eccentric mechanism or an electromagnetic mechanism

The apparatus may be operated by a hydraulic mechanism, in which casethe apparatus may comprise a pump.

In a second aspect there is provided a system that comprises anapparatus as described above.

In one embodiment the system comprises at least one switch implantablein the patient for manually and non-invasively controlling theapparatus.

In one embodiment the system comprises a hydraulic device having animplantable hydraulic reservoir, which is hydraulically connected to theapparatus, wherein the apparatus is adapted to be non-invasivelyregulated by manually pressing the hydraulic reservoir.

In one embodiment the system comprises a wireless remote control fornon-invasively controlling the apparatus. The wireless remote controlmay comprise at least one external signal transmitter and/or receiver,further comprising an internal signal receiver and/or transmitterimplantable in the patient for receiving signals transmitted by theexternal signal transmitter or transmitting signals to the externalsignal receiver.

In one embodiment the wireless remote control transmits at least onewireless control signal for controlling the apparatus.

In one embodiment the wireless control signal comprises a frequency,amplitude, or phase modulated signal or a combination thereof.

In one embodiment the wireless remote control transmits anelectromagnetic carrier wave signal for carrying the control signal.

One embodiment comprises a wireless energy-transmission device fornon-invasively energizing implantable energy consuming components of theapparatus or the system with wireless energy.

In one embodiment there is provided a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. The signal may be an analogue signal, a digitalsignal, or a combination of an analogue and digital signal

The wireless energy may be different in different embodiments, forexample: an electric field, a magnetic field, or a combined electric andmagnetic field.

The control signal may be different in different embodiments, forexample an electric field, a magnetic field, or a combined electric andmagnetic field.

In a main embodiment there is provided an implantable internal energysource for powering implantable energy consuming components of theapparatus.

In one embodiment there is provided an external energy source fortransferring energy in a wireless mode, wherein the internal energysource is chargeable by the energy transferred in the wireless mode.

In one embodiment there is provided a sensor or measuring device sensingor measuring a functional parameter correlated to the transfer of energyfor charging the internal energy source, and a feedback device forsending feedback information from inside the patient's body to theoutside thereof, the feedback information being related to thefunctional parameter sensed by the sensor or measured by the measuringdevice.

One main embodiment further comprises a feedback device for sendingfeedback information from inside the patient's body to the outsidethereof, the feedback information being related to at least one of aphysiological parameter of the patient and a functional parameterrelated to the apparatus.

In one embodiment there is provided a sensor and/or a measuring deviceand an implantable internal control unit for controlling the apparatusin response to information being related to at least one of aphysiological parameter of the patient sensed by the sensor or measuredby the measuring device and a functional parameter related to theapparatus sensed by the sensor or measured by the measuring device. Thephysiological parameter may be pressure, motility or movement.

In one embodiment there is provided an external data communicator and animplantable internal data communicator communicating with the externaldata communicator, wherein the internal communicator feeds data relatedto the apparatus or the patient to the external data communicator and/orthe external data communicator feeds data to the internal datacommunicator.

In one embodiment there is provided a motor or a pump for operating theapparatus.

In one embodiment there is provided a hydraulic operation device foroperating the apparatus.

In one embodiment there is provided an operation device for operatingthe apparatus, wherein the operation device comprises a servo designedto decrease the force needed for the operation device to operate theapparatus instead the operation device acting a longer way, increasingthe time for a determined action.

In one embodiment there is provided a operation device for operating theapparatus, wherein the wireless energy is used in its wireless state todirectly power the operation device to create kinetic energy for theoperation of the apparatus, as the wireless energy is being transmittedby the energy-transmission device.

In one embodiment there is provided an energy-transforming device fortransforming the wireless energy transmitted by the energy-transmissiondevice from a first form into a second form energy.

In one embodiment the energy-transforming device directly powersimplantable energy consuming components of the apparatus with the secondform energy, as the energy-transforming device transforms the first formenergy transmitted by the energy-transmission device into the secondform energy.

In one embodiment the second form energy comprises at least one of adirect current, pulsating direct current and an alternating current.

In one embodiment there is provided an implantable accumulator, whereinthe second form energy is used at least partly to charge theaccumulator.

In one embodiment the energy of the first or second form comprises atleast one of magnetic energy, kinetic energy, sound energy, chemicalenergy, radiant energy, electromagnetic energy, photo energy, nuclearenergy thermal energy, non-magnetic energy, non-kinetic energy,non-chemical energy, non-sonic energy, non-nuclear energy andnon-thermal energy.

In one embodiment there are provided implantable electrical componentsincluding at least one voltage level guard and/or at least one constantcurrent guard.

In one embodiment there is provided a control device for controlling thetransmission of wireless energy from the energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto, the system furthercomprising a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

In one embodiment the determination device is adapted to detect a changein the energy balance, and the control device controls the transmissionof wireless energy based on the detected energy balance change.

In one embodiment the determination device is adapted to detect adifference between energy received by the internal energy receiver andenergy used for the implantable energy consuming components of theapparatus, and the control device controls the transmission of wirelessenergy based on the detected energy difference.

In one embodiment the energy-transmission device comprises a coil placedexternally to the human body, further comprising an implantable energyreceiver to be placed internally in the human body and an electriccircuit connected to power the external coil with electrical pulses totransmit the wireless energy, the electrical pulses having leading andtrailing edges, the electric circuit adapted to vary first timeintervals between successive leading and trailing edges and/or secondtime intervals between successive trailing and leading edges of theelectrical pulses to vary the power of the transmitted wireless energy,the energy receiver receiving the transmitted wireless energy having avaried power.

In one embodiment the electric circuit is adapted to deliver theelectrical pulses to remain unchanged except varying the first and/orsecond time intervals.

In one embodiment the electric circuit has a time constant and isadapted to vary the first and second time intervals only in the range ofthe first time constant, so that when the lengths of the first and/orsecond time intervals are varied, the transmitted power over the coil isvaried.

In one embodiment there is provided a system comprising an implantableinternal energy receiver for receiving wireless energy, the energyreceiver having an internal first coil and a first electronic circuitconnected to the first coil, and an external energy transmitter fortransmitting wireless energy, the energy transmitter having an externalsecond coil and a second electronic circuit connected to the secondcoil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, the system further comprising a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off.

In one embodiment there is a an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil, wherein the external second coilof the energy transmitter transmits wireless energy which is received bythe first coil of the energy receiver, the system further comprising afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorsbetween the first and second coils.

In one embodiment the transmitted energy may be regulated depending onthe obtained coupling factor.

In one embodiment there is provided a system wherein the external secondcoil is adapted to be moved in relation to the internal first coil toestablish the optimal placement of the second coil, in which thecoupling factor is maximized.

In one embodiment there is provided a system wherein the external secondcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

In a third aspect there is provided an operation method using anapparatus or system according to the above further comprising the stepsof: a)creating an opening in the skin or penis wall of the male patient,b) dissecting an one area of the sexually responsive tissue, c) placingthe elongated prosthesis including the vibrator within at least onecorpus cavernosum, adapted to postoperatively achieve erection andvibrate the hydraulic fluid within said implants to stimulate saidsexually responsive tissue on patient command.

In one embodiment there is provided an operation method comprising thestep of placing an operation device and a power source within the body.

In one embodiment the operation method comprises placing a vibratorcomprising placing an integrated unit comprising the vibrator and anoperation device in the same integrated unit.

In one embodiment the operation method comprises placing a power sourcecomprising, placing an control unit and a rechargeable battery remotefrom said sexually responsive tissue.

In one embodiment the operation method comprises controlling saidvibrator post-operatively and non-invasively from outside the body.

In one embodiment the operation method comprises the step of creating anopening in the skin or penis wall of the male patient comprising,a)inserting a tube or needle into the patients body, b) filling the tubeor needle with a gas and thereby expanding a cavity within the malepatients body, c) inserting at least two laparoscopic trocars into saidcavity, d) inserting at least one camera trough at least onelaparoscopic trocar, e) inserting at least one dissecting tool throughat least one laparoscopic trocar.

In one embodiment the vibrator is adapted to be implanted in any, oreach, of the corpus cavernosum of the penis of the male patient.

In one embodiment the vibrator is adapted to be implanted outside of thecorpus cavernosum but in, or in contact with, sexually responsive tissueof the penis of the male patient.

In one embodiment the vibrator is adapted to be implanted in thevicinity of, or in contact with, the glans penis of the penis of themale patient.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described in more detail by way ofnon-limiting examples and with reference to the accompanying drawings,in which:

FIG. 1 a illustrates a system for treating sexual dysfunction in a malepatient, wherein the system includes an apparatus of the inventionimplanted in a patient.

FIGS. 1 b-1 e illustrates the system and apparatus in more detail.

FIGS. 2-16 schematically show various embodiments of the system forwirelessly powering the apparatus shown in FIG. 1.

FIG. 17 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of theapparatus shown in FIG. 1.

FIG. 18 schematically shows an embodiment of the system, in which theapparatus is operated with wire bound energy.

FIG. 19 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the apparatus shown in FIG. 1.

FIG. 20 is a circuit for the arrangement shown in FIG. 19, according toa possible implementation example.

FIGS. 21-27 show various ways of arranging hydraulic or pneumaticpowering of an apparatus implanted in a patient.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Before the invention is disclosed and described in detail, it is to beunderstood that this invention is not limited to particular surgicalsteps, configurations, method steps, substrates, and materials disclosedherein as such surgical steps, configurations, method steps, substrates,and materials may vary somewhat. It is also to be understood that theterminology employed herein is used for the purpose of describingparticular embodiments only and is not intended to be limiting since thescope of the present invention is limited only by the appended claimsand equivalents thereof.

It must be noted that, as used in this specification and the appendedclaims, the singular forms “a”, “an” and “the” include plural referentsunless the context clearly dictates otherwise.

If nothing else is defined, any terms and scientific terminology usedherein are intended to have the meanings commonly understood by those ofskill in the art to which this invention pertains.

“contact”: union or junction of surfaces, including but not limited to:touching, contact, stroking and poking.

“vibration”: repeatedly changing of place or position or posture,including but not limited to: vibration, oscillation, kneading,rotation, alternating expansion and contraction.

“Sexually responsive tissue of the penis”: Sexually responsive tissue ofthe male penis including the penis, the penis glans, the corporacavernosa, the corpus cavernosum urethrae.

“in the region of”: in, close to or in the vicinity of.

The terms “vibrator” and “vibration device” are used interchangeably inthis application.

The term “apparatus” refers to the vibrator or vibration device, eitheralone or in combination with a penile prosthesis.

The FIG. 1 a illustrates a system for treating a sexually dysfunctionalmale patient comprising an apparatus 10 of the present inventioncomprising a vibrator placed in a patient. An implantedenergy-transforming device 1002 is adapted to supply energy consumingcomponents of the apparatus with energy via a power supply line 1003. Anexternal energy-transmission device 1004 for non-invasively energizingthe apparatus 10 transmits energy by at least one wireless energysignal. The implanted energy-transforming device 1002 transforms energyfrom the wireless energy signal into electric energy which is suppliedvia the power supply line 1003.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 1004 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 1002 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 1004 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 10 is operable in response to the energy of the second form.The energy-transforming device 1002 may directly power the apparatuswith the second form energy, as the energy-transforming device 1002transforms the first form energy transmitted by the energy-transmissiondevice 1004 into the second form energy. The system may further includean implantable accumulator, wherein the second form energy is used atleast partly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 1004 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 1004. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 1004 maybe used to directly power the operation device to create kinetic energyfor the operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 1002 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 1004 also includes a wirelessremote control 1200 having an external signal transmitter fortransmitting a wireless control signal for non-invasively controllingthe apparatus. The control signal is received by an implanted signalreceiver which may be incorporated in the implanted energy-transformingdevice 1002 or be separate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 1 b shows an apparatus comprising a penile implant 10 a having avibrator 1001, implanted in the corpus cavernosum of a penis 30 wherethe penile implant 10 a is in its relaxed state. The penile implant 10 ais connected to the energy-transforming device 1002 through a powersupply line 1003. An external energy-transmission device 1004 forenergizing the apparatus 10 transmits energy by at least one wirelessenergy signal. The system 1000 can be controlled with a remote control1200. Also a subcutaneous control switch 1006 can be used to control theapparatus 10. In one embodiment a sensor 1070 measures at least onephysiological or functional parameter. The location of the sensor 1070is adapted to the circumstances, e.g. which parameter that should bemeasured. The sensor 1070 may e.g. be connected to theenergy-transforming device 1002 or the control unit 1041 via acommunication line 1072 that also may supply power to the sensor 1070.

In FIG. 1 b letters a, b, c and d indicates alternative locations forthe vibrator 1001. The vibrator 1001 may of course be implanted directlyin the penis or in the region of the penis and need not be located in apenile implant 10 a.

The energy-transforming device 1002 may comprise at least one itemselected from the group consisting of; a control unit 1041, a battery1042, a sensor 1043, a motor 1044, a pump 1045, a reservoir 1046. Theitem 1047 may be an injection port. The items are selected depending onthe circumstances, e.g. if the apparatus 10 is electrically,hydraulically or mechanically operated.

If a non-rechargeable battery is used the energy-transforming device1002 may be omitted but the items 1041 to 1047 may be used as suitable,and be connected to the apparatus 10 and sensor 1070 as suitable. Ife.g. the apparatus 10 is hydraulically operated it may e.g. be suitableto use a control unit 1041, a pump 1045 and/or a reservoir 1046.

In general, any item, or combinations of items, described and suitedtherefore, may be connected to the apparatus 10 via the power supplyline 1003. The actual item, or combinations of items, is chosendepending on the circumstances, e.g. if the apparatus 10 iselectrically, hydraulically or mechanically operated.

If e.g. the apparatus 10 is mechanically operated it may be connected toa motor 1044 via the power supply line 1003 which in this case may be awire or bowden cable. A control unit 1041 may be connected to the motor1044.

If e.g. the apparatus 10 is electrically operated it may be suitable toconnect it to a source of electrical energy 1002 or 1042 via the powersupply line 1003 which in this case may be an electrical conduit. Acontrol unit 1041 may be connected to the source of electrical energy1002 or 1042.

The apparatus 10 suitably comprises a vibrator 1001 and suitably isimplanted in or in contact with the sexually responsive tissue of thepenis 30 of the patient.

FIG. 1 c shows one exemplary location of a vibrator 1001 in each penileimplant 10 a of a system 1000. The apparatus 10 in the form of thepenile implants 10 a are connected to the energy-transforming device1002 through a power supply line 1003. An external energy-transmissiondevice 1004 for energizing the apparatus 10 transmits energy by at leastone wireless energy signal. The system 1000 can be controlled with aremote control 1200. Also a subcutaneous control switch 1006 under theskin 1005 of the patient can be used to control the apparatus 10.

FIG. 1 d schematically shows one exemplary embodiment of the vibrator1001 comprising an outer shell 602, a motor 604, a first motor shaft606, an eccentric element 608 eccentrically mounted to the first motorshaft 606, a second shaft 610 which suitably is supported by a bearingmounted to the outer shell 602. The motor 604 may comprise a gear box611 that transforms the speed of rotation of the motor to a suitablespeed.

FIG. 1 e illustrates an electromagnetic device 1001 b which is anothermeans or exemplary embodiment of making the vibrator 1001 move.

FIG. 2 illustrates the system 1000 of FIG. 1 a in the form of a moregeneralized block diagram showing the apparatus 10, theenergy-transforming device 1002 powering the apparatus 10 via powersupply line 1003, and the external energy-transmission device 1004, Thepatient's skin 1005, generally shown by a vertical line, separates theinterior of the patient to the right of the line from the exterior tothe left of the line.

FIG. 3 shows an embodiment of the invention identical to that of FIG. 2,except that a reversing device in the form of an electric switch 1006operable for example by polarized energy also is implanted in thepatient for reversing the apparatus 10. When the switch is operated bypolarized energy the wireless remote control of the externalenergy-transmission device 1004 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 1002transforms the wireless polarized energy into a polarized current foroperating the electric switch 1006. When the polarity of the current isshifted by the implanted energy-transforming device 1002 the electricswitch 1006 reverses the function performed by the apparatus 10.

FIG. 4 shows an embodiment of the invention identical to that of FIG. 2,except that an operation device 1007 implanted in the patient foroperating the apparatus 10 is provided between the implantedenergy-transforming device 1002 and the apparatus 10. This operationdevice can be in the form of a motor 1007, such as an electricservomotor. The motor 1007 is powered with energy from the implantedenergy-transforming device 1002, as the remote control of the externalenergy-transmission device 1004 transmits a wireless signal to thereceiver of the implanted energy-transforming device 1002.

FIG. 5 shows an embodiment of the invention identical to that of FIG. 2,except that it also comprises an operation device is in the form of anassembly 1008 including a motor/pump unit 1009 and a fluid reservoir1010 is implanted in the patient. In this case the apparatus 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 1009 from the fluid reservoir 1010 through a conduit 1011 to theapparatus 10 to operate the apparatus, and hydraulic fluid is pumped bythe motor/pump unit 1009 back from the apparatus 10 to the fluidreservoir 1010 to return the apparatus to a starting position. Theimplanted energy-transforming device 1002 transforms wireless energyinto a current, for example a polarized current, for powering themotor/pump unit 1009 via an electric power supply line 1012.

Instead of a hydraulically operated apparatus 10, it is also envisagedthat the operation device comprises a pneumatic operation device. Inthis case, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 1002 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 6 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, theapparatus 10, in this case hydraulically operated, and the implantedenergy-transforming device 1002, and further comprising a hydraulicfluid reservoir 1013, a motor/pump unit 1009 and an reversing device inthe form of a hydraulic valve shifting device 1014, all implanted in thepatient. Of course the hydraulic operation could easily be performed byjust changing the pumping direction and the hydraulic valve maytherefore be omitted. The remote control may be a device separated fromthe external energy-transmission device or included in the same. Themotor of the motor/pump unit 1009 is an electric motor. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the implanted energy-transformingdevice 1002 powers the motor/pump unit 1009 with energy from the energycarried by the control signal, whereby the motor/pump unit 1009distributes hydraulic fluid between the hydraulic fluid reservoir 1013and the apparatus 10. The remote control of the externalenergy-transmission device 1004 controls the hydraulic valve shiftingdevice 1014 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 1009 fromthe hydraulic fluid reservoir 1013 to the apparatus 10 to operate theapparatus, and another opposite direction in which the fluid is pumpedby the motor/pump unit 1009 back from the apparatus 10 to the hydraulicfluid reservoir 1013 to return the apparatus to a starting position.

FIG. 7 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, theapparatus 10, the implanted energy-transforming device 1002, animplanted internal control unit 1015 controlled by the wireless remotecontrol of the external energy-transmission device 1004, an implantedaccumulator 1016 and an implanted capacitor 1017. The internal controlunit 1015 arranges storage of electric energy received from theimplanted energy-transforming device 1002 in the accumulator 1016, whichsupplies energy to the apparatus 10. In response to a control signalfrom the wireless remote control of the external energy-transmissiondevice 1004, the internal control unit 1015 either releases electricenergy from the accumulator 1016 and transfers the released energy viapower lines 1018 and 1019, or directly transfers electric energy fromthe implanted energy-transforming device 1002 via a power line 1020, thecapacitor 1017, which stabilizes the electric current, a power line 1021and the power line 1019, for the operation of the apparatus 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the apparatus 10 according to a pre-programmedtime-schedule or to input from any sensor, e.g. sensor 1070, sensing anypossible physiological parameter of the patient or any functionalparameter of the system.

In accordance with an alternative, the capacitor 1017 in the embodimentof FIG. 7 may be omitted. In accordance with another alternative, theaccumulator 1016 in this embodiment may be omitted.

FIG. 8 shows an embodiment of the invention identical to that of FIG. 2,except that a battery 1022 for supplying energy for the operation of theapparatus 10 and an electric switch 1023 for switching the operation ofthe apparatus 10 also are implanted in the patient. The electric switch1023 may be controlled by the remote control and may also be operated bythe energy supplied by the implanted energy-transforming device 1002 toswitch from an off mode, in which the battery 1022 is not in use, to anon mode, in which the battery 1022 supplies energy for the operation ofthe apparatus 10.

FIG. 9 shows an embodiment of the invention identical to that of FIG. 8,except that an internal control unit 1015 controllable by the wirelessremote control of the external energy-transmission device 1004 also isimplanted in the patient. In this case, the electric switch 1023 isoperated by the energy supplied by the implanted energy-transformingdevice 1002 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 1015 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 1015 torelease electric energy from the battery 1022 for the operation of theapparatus 10.

FIG. 10 shows an embodiment of the invention identical to that of FIG.9, except that an accumulator 1016 is substituted for the battery 1022and the implanted components are interconnected differently. In thiscase, the accumulator 1016 stores energy from the implantedenergy-transforming device 1002. In response to a control signal fromthe wireless remote control of the external energy-transmission device1004, the internal control unit 1015 controls the electric switch 1023to switch from an off mode, in which the accumulator 1016 is not in use,to an on mode, in which the accumulator 1016 supplies energy for theoperation of the apparatus 10. The accumulator may be combined with orreplaced by a capacitor.

FIG. 11 shows an embodiment of the invention identical to that of FIG.10, except that a battery 1022 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 controlsthe accumulator 1016 to deliver energy for operating the electric switch1023 to switch from an off mode, in which the battery 1022 is not inuse, to an on mode, in which the battery 1022 supplies electric energyfor the operation of the apparatus 10.

Alternatively, the electric switch 1023 may be operated by energysupplied by the accumulator 1016 to switch from an off mode, in whichthe wireless remote control is prevented from controlling the battery1022 to supply electric energy and is not in use, to a standby mode, inwhich the wireless remote control is permitted to control the battery1022 to supply electric energy for the operation of the apparatus 10.

It should be understood that the switch 1023 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 12 shows an embodiment of the invention identical to that of FIG.8, except that a motor 1007, a mechanical reversing device in the formof a gear box 1024, and an internal control unit 1015 for controllingthe gear box 1024 also are implanted in the patient. The internalcontrol unit 1015 controls the gear box 1024 to reverse the functionperformed by the apparatus 10 (mechanically operated). Even simpler isto switch the direction of the motor electronically. The gear boxinterpreted in its broadest embodiment may stand for a servo arrangementsaving force for the operation device in favour of longer stroke to act.

FIG. 13 shows an embodiment of the invention identical to that of FIG.19 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 1015 is powered by thebattery 1022 when the accumulator 1016, suitably a capacitor, activatesthe electric switch 1023 to switch to an on mode. When the electricswitch 1023 is in its on mode the internal control unit 1015 ispermitted to control the battery 1022 to supply, or not supply, energyfor the operation of the apparatus 10.

FIG. 14 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the apparatus 10, the internal control unit 1015,motor or pump unit 1009, and the external energy-transmission device1004 including the external wireless remote control. As alreadydescribed above the wireless remote control transmits a control signalwhich is received by the internal control unit 1015, which in turncontrols the various implanted components of the apparatus.

A feedback device, preferably comprising a sensor or measuring device1025, may be implanted in the patient for sensing a physiologicalparameter of the patient. The physiological parameter may be at leastone selected from the group consisting of pressure, volume, diameter,stretching, elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysiological parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 1025 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, any electrical parameter, pressure, volume,diameter, stretch, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 1015, or alternatively the external wirelessremote control of the external energy-transmission device 1004, maycontrol the apparatus 10 in response to signals from the sensor 1025. Atransceiver may be combined with the sensor 1025 for sending informationon the sensed physiological parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the internal control unit 1015 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit1015 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the apparatus 10 from inside thepatient's body to the outside thereof.

Where the motor/pump unit 1009 and battery 1022 for powering themotor/pump unit 1009 are implanted, information related to the chargingof the battery 1022 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 15 shows an alternative embodiment wherein the apparatus 10 isregulated from outside the patient's body.

The system 1000 comprises a battery 1022 connected to the apparatus 10via a subcutaneous electric switch 1026. Thus, the regulation of theapparatus 10 is performed non-invasively by manually pressing thesubcutaneous switch, whereby the operation of the apparatus 10 isswitched on and off. It will be appreciated that the shown embodiment isa simplification and that additional components, such as an internalcontrol unit or any other part disclosed in the present application canbe added to the system. Two subcutaneous switches may also be used. Inthe preferred embodiment one implanted switch sends information to theinternal control unit to perform a certain predetermined performance andwhen the patient press the switch again the performance is reversed.

FIG. 16 shows an alternative embodiment, wherein the system 1000comprises a hydraulic fluid reservoir 1013 hydraulically connected tothe apparatus. Non-invasive regulation is performed by manually pressingthe hydraulic reservoir connected to the apparatus.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to theapparatus or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.

FIG. 17 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the apparatus or system, or related to aphysiological parameter of the patient, in order to supply an accurateamount of energy to an implanted internal energy receiver 1002 connectedto implanted energy consuming components of the apparatus 10. Such anenergy receiver 1002 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 1004 a located outside thepatient and is received by the internal energy receiver 1002 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the apparatus 10 via a switch 1026. An energy balance is determinedbetween the energy received by the internal energy receiver 1002 and theenergy used for the apparatus 10, and the transmission of wirelessenergy is then controlled based on the determined energy balance. Theenergy balance thus provides an accurate indication of the correctamount of energy needed, which is sufficient to operate the apparatus 10properly, but without causing undue temperature rise.

In FIG. 17 the patient's skin is indicated by a vertical line 1005.Here, the energy receiver comprises an energy-transforming device 1002located inside the patient, preferably just beneath the patient's skin1005. Generally speaking, the implanted energy-transforming device 1002may be placed in the abdomen, thorax, muscle fascia (e.g. in theabdominal wall), subcutaneously, or at any other suitable location. Theimplanted energy-transforming device 1002 is adapted to receive wirelessenergy E transmitted from the external energy source 1004 a provided inan external energy-transmission device 1004 located outside thepatient's skin 1005 in the vicinity of the implanted energy-transformingdevice 1002.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 1004 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 1002. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the apparatus, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 1004 b that controls the externalenergy source 1004 a based on the determined energy balance to regulatethe amount of transferred energy. In order to transfer the correctamount of energy, the energy balance and the required amount of energyis determined by means of a determination device including an implantedinternal control unit 1015 connected between the switch 1026 and theapparatus 10. The internal control unit 1015 may thus be arranged toreceive various measurements obtained by suitable sensors or the like,not shown, measuring certain characteristics of the apparatus 10,somehow reflecting the required amount of energy needed for properoperation of the apparatus 10. Moreover, the current condition of thepatient may also be detected by means of suitable measuring devices orsensors, in order to provide parameters reflecting the patient'scondition. Hence, such characteristics and/or parameters may be relatedto the current state of the apparatus 10, such as power consumption,operational mode and temperature, as well as the patient's conditionreflected by parameters such as; body temperature, blood pressure,heartbeats and breathing. Other kinds of physiological parameters of thepatient and functional parameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 1016 mayoptionally be connected to the implanted energy-transforming device 1002via the control unit 1015 for accumulating received energy for later useby the apparatus 10. Alternatively or additionally, characteristics ofsuch an accumulator, also reflecting the required amount of energy, maybe measured as well. The accumulator may be replaced by a rechargeablebattery, and the measured characteristics may be related to the currentstate of the battery, any electrical parameter such as energyconsumption voltage, temperature, etc. In order to provide sufficientvoltage and current to the apparatus 10, and also to avoid excessiveheating, it is clearly understood that the battery should be chargedoptimally by receiving a correct amount of energy from the implantedenergy-transforming device 1002, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 1015. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 1015 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus 10, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit1015 is further connected to an internal signal transmitter 1027,arranged to transmit a control signal reflecting the determined requiredamount of energy, to an external signal receiver 1004 c connected to theexternal control unit 1004 b. The amount of energy transmitted from theexternal energy source 1004 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 1004 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 1004 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 1004 b, thus integrating the above-describedfunction of the internal control unit 1015 in the external control unit1004 b. In that case, the internal control unit 1015 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 1027 which sends the measurements over to the externalsignal receiver 1004 c and the external control unit 1004 b. The energybalance and the currently required amount of energy can then bedetermined by the external control unit 1004 b based on those sensormeasurements.

Hence, the present solution according to the arrangement of FIG. 17employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the apparatus. The apparatus may use thereceived energy either for consuming or for storing the energy in animplanted energy source or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken internally to specificallyoperate the apparatus.

The internal signal transmitter 1027 and the external signal receiver1004 c may be implemented as separate units using suitable signaltransfer means, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 1027 and the externalsignal receiver 1004 c may be integrated in the implantedenergy-transforming device 1002 and the external energy source 1004 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 17, the switch 1026is either separate and controlled by the internal control unit 1015, orintegrated in the internal control unit 1015. It should be understoodthat the switch 1026 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 17 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 1015 of the determinationdevice. A control signal reflecting the required amount of energy isalso created by the internal control unit 1015, and the control signalis transmitted from the internal signal transmitter 1027 to the externalsignal receiver 1004 c. Alternatively, the energy balance can bedetermined by the external control unit 1004 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 1004 a can then be regulated bythe external control unit 1004 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 1004 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 18, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 18,wherein an external switch 1026 is interconnected between the externalenergy source 1004 a and an operation device, such as an electric motor1007 operating the apparatus 10. An external control unit 1004 bcontrols the operation of the external switch 1026 to effect properoperation of the apparatus 10.

FIG. 19 illustrates different embodiments for how received energy can besupplied to and used by the apparatus 10. Similar to the example of FIG.17, an internal energy receiver 1002 receives wireless energy E from anexternal energy source 1004 a which is controlled by a transmissioncontrol unit 1004 b. The internal energy receiver 1002 may comprise aconstant voltage circuit, indicated as a dashed box “constant V” in thefigure, for supplying energy at constant voltage to the apparatus 10.The internal energy receiver 1002 may further comprise a constantcurrent circuit, indicated as a dashed box “constant C” in the figure,for supplying energy at constant current to the apparatus 10.

The apparatus 10 comprises an energy consuming part 10 b, which may be amotor, pump, restriction device, or any other medical appliance thatrequires energy for its electrical operation. The apparatus 10 mayfurther comprise an energy storage device 10 c for storing energysupplied from the internal energy receiver 1002. Thus, the suppliedenergy may be directly consumed by the energy consuming part 10 b, orstored by the energy storage device 10 c, or the supplied energy may bepartly consumed and partly stored. The apparatus 10 may further comprisean energy stabilizing unit 10 d for stabilizing the energy supplied fromthe internal energy receiver 1002. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 1002 may furtherbe accumulated and/or stabilized by a separate energy stabilizing unit1028 located outside the apparatus 10, before being consumed and/orstored by the apparatus 10. Alternatively, the energy stabilizing unit1028 may be integrated in the internal energy receiver 1002. In eithercase, the energy stabilizing unit 1028 may comprise a constant voltagecircuit and/or a constant current circuit.

It should be noted that FIG. 17 and FIG. 19 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 20 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted components of theapparatus, more energy is transferred and thus charged into the energysource. The output signal from the circuit is typically feed to an A/Dconverter and converted into a digital format. The digital informationcan then be sent to the external energy-transmission device allowing itto adjust the level of the transmitted energy. Another possibility is tohave a completely analog system that uses comparators comparing theenergy balance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 20 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatus ofthe present invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, L1, is included in the schematic FIG. 3; the transmitting parts ofthe system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 20and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 20 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 1006 of FIG. 3 could be incorporated in any of theembodiments of FIGS. 6-12, the hydraulic valve shifting device 1014 ofFIG. 6 could be incorporated in the embodiment of FIG. 5, and the gearbox 1024 could be incorporated in the embodiment of FIG. 4. Pleaseobserve that the switch simply could mean any electronic circuit orcomponent.

The embodiments described in connection with FIGS. 17, 19 and 20identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming components of an electricallyoperable apparatus. Such a method and system will be defined in generalterms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the apparatus. Thetransmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physiological parameters of the medical deviceand/or physiological parameters of the patient are determined, theenergy may be transmitted for consumption and storage according to atransmission rate per time unit which is determined based on saidparameters. The total amount of transmitted energy may also bedetermined based on said parameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising an apparatus as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming components of the apparatus. In its broadestsense, the system comprises a control device for controlling thetransmission of wireless energy from an energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto. The system furthercomprises a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the apparatus, and the control device controls the transmission        of wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for the apparatus is consumed to operate the        apparatus, and/or stored in at least one energy storage device        of the apparatus.    -   Where electrical and/or physiological parameters of the        apparatus and/or physiological parameters of the patient are        determined, the energy-transmission device transmits the energy        for consumption and storage according to a transmission rate per        time unit which is determined by the determination device based        on said parameters. The determination device also determines the        total amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIGS. 21-24 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted apparatus accordingto the invention.

FIG. 21 shows a system as described above with. The system comprises animplanted apparatus 10 and further a separate regulation reservoir 1013,a one way pump 1009 and an alternate valve 1014.

FIG. 22 shows the apparatus 10 and a fluid reservoir 1013. By moving thewall of the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the apparatus may be performedwithout any valve, just free passage of fluid any time by moving thereservoir wall.

FIG. 23 shows the apparatus 10, a two way pump 1009 and the regulationreservoir 1013.

FIG. 24 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 1013 and a servo reservoir 1050. Theservo reservoir 1050 mechanically controls an implanted apparatus 10 viaa mechanical interconnection 1054. The apparatus has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 1052 in fluid connection with the apparatus 10. Alternatively,the cavity contains compressible gas, which can be compressed andexpanded under the control of the servo reservoir 1050.

The servo reservoir 1050 can also be part of the apparatus itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 25 a-c. InFIG. 25 a, a flexible subcutaneous regulation reservoir 1013 is shownconnected to a bulge shaped servo reservoir 1050 by means of a conduit1011. This bellow shaped servo reservoir 1050 is comprised in a flexibleapparatus 10. In the state shown in FIG. 25 a, the servo reservoir 1050contains a minimum of fluid and most fluid is found in the regulationreservoir 1013. Due to the mechanical interconnection between the servoreservoir 1050 and the apparatus 10, the outer shape of the apparatus 10is contracted, i.e., it occupies less than its maximum volume. Thismaximum volume is shown with dashed lines in the figure.

FIG. 25 b shows a state wherein a user, such as the patient in with theapparatus is implanted, presses the regulation reservoir 1013 so thatfluid contained therein is brought to flow through the conduit 1011 andinto the servo reservoir 1050, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the apparatus 10so that it occupies its maximum volume, thereby stretching the stomachwall (not shown), which it contacts.

The regulation reservoir 1013 is preferably provided with means 1013 afor keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 26 and 27 a-c. The block diagramshown in FIG. 26 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir1013 and a servo reservoir 1050. The servo reservoir 1050 mechanicallycontrols a larger adjustable reservoir 1052 via a mechanicalinterconnection 1054. An implanted apparatus 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 1052 by supply of hydraulic fluid from the largeradjustable reservoir 1052 in fluid connection with the apparatus 10.

An example of this embodiment will now be described with reference toFIG. 27 a-c. Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 1013 is in fluid connection with a bellow shaped servoreservoir 1050 by means of a conduit 1011. In the first closed system1013, 1011, 1050 shown in FIG. 27 a, the servo reservoir 1050 contains aminimum of fluid and most fluid is found in the regulation reservoir1013.

The servo reservoir 1050 is mechanically connected to a largeradjustable reservoir 1052, in this example also having a bellow shapebut with a larger diameter than the servo reservoir 1050. The largeradjustable reservoir 1052 is in fluid connection with the apparatus 10.This means that when a user pushes the regulation reservoir 1013,thereby displacing fluid from the regulation reservoir 1013 to the servoreservoir 1050, the expansion of the servo reservoir 1050 will displacea larger volume of fluid from the larger adjustable reservoir 1052 tothe apparatus 10. In other words, in this reversed servo, a small volumein the regulation reservoir is compressed with a higher force and thiscreates a movement of a larger total area with less force per area unit.

Like in the previous embodiment described above with reference to FIGS.25 a-c, the regulation reservoir 1013 is preferably provided with means1013 a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

Other features and uses of the invention and their associated advantageswill be evident to a person skilled in the art upon reading thedescription and the examples.

It is to be understood that this invention is not limited to theparticular embodiments shown here. The following examples are providedfor illustrative purposes and are not intended to limit the scope of theinvention since the scope of the present invention is limited only bythe appended claims and equivalents thereof.

1. An apparatus for treating a sexually dysfunctional male patient,comprising an implantable at least one vibrator adapted to be implantedwithin at least one corpus cavernosum of a human patient, wherein saidvibrator is adapted to cause vibration in at least one of the corpuscavernosum for stimulating the sexually responsive tissue of the penis.2. The apparatus according to claim 1, where the at least one vibratoris adapted to create vibration with a frequency from 0.1 to 10 000 Hz.3. The apparatus according to claim 1, where the at least one vibratoris adapted to create movement with an amplitude of from 0.01 to 30 mm.4. The apparatus according to claim 1, where the at least one vibratoris controlled by an endogenous signal.
 5. The apparatus according toclaim 1, where the at least one vibrator is adapted to create vibrationsalong more than one axis.
 6. The apparatus according to claim 1, whereinthe at least one vibrator comprises a mechanical device, wherein thevibration is achieved by said mechanical device.
 7. The apparatusaccording to claim 6, wherein the mechanical device comprises anelectric motor having an shaft, wherein the vibration is achieved bysaid electric motor.
 8. The apparatus according to claim 7, comprisingan eccentric mechanism connected to the shaft of the motor, wherein thevibration is achieved by the eccentric mechanism.
 9. The apparatusaccording to claim 1, comprising an electromagnetic mechanism, whereinthe vibration is achieved by the electromagnetic mechanism.
 10. Theapparatus according to claim 1, comprising a piezoelectric element,wherein the vibration is achieved by the piezoelectric element.
 11. Theapparatus according to claim 1, wherein the vibrator comprises ahydraulic device, wherein the vibration is achieved by said hydraulicdevice.
 12. The apparatus according to claim 1, comprising at least twovibrators, adapted to be placed in the two corpus cavernosa in theregion of the sexually responsive tissue of the penis.
 13. The apparatusaccording to claim 1, wherein the at least one vibrator is adapted to beimplanted outside of the corpus cavernosum but in, or in contact with,sexually responsive tissue of the penis of the male patient.
 14. Theapparatus according to claim 1, wherein the at least one vibrator isadapted to be implanted in the vicinity of, or in contact with, theglans penis of the penis of the male patient.
 15. The apparatusaccording to claim 1, where the at least one vibrator is adapted to beprovided in at least one elongated corpus cavernosum reservoir.
 16. Theapparatus according to claim 15, comprising at least one elongatedcorpus cavernosum prosthesis comprising said reservoir, wherein said atleast one vibrator is provided in the at least one prosthesis.
 17. Theapparatus according to claim 16, wherein the prosthesis is hydraulicallyoperated.
 18. The apparatus according to claim 16, wherein theprosthesis is adapted to be adjusted to temporarily achieve enlargedstatus of the penis.
 19. The apparatus according to claim 16, whereinthe prosthesis is made of silicone.
 20. The apparatus according to claim18, wherein the hydraulically operated prosthesis is powered andcontrollable from outside the patient's body. 21.-79. (canceled)